The safety of studies with intravenous Δ⁹-tetrahydrocannabinol in humans, with case histories.
Michelle Carbuto, R Andrew Sewell, Ashley H Williams, Kim Forselius-Bielen, Gabriel Braley, Jacqueline Elander, Brian Pittman, Ashley Schnakenberg, Savita Bhakta, Edward Perry, Mohini Ranganathan, Deepak Cyril D'Souza
Psychopharmacology February 2012 DOI: 10.1007/s00213-011-2417-y (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Retrospective review Peer reviewed |
|---|---|
| Sample size | 266 |
| Population | Subjects from 11 intravenous THC studies, including 14 schizophrenia patients and 252 healthy subjects (76 frequent cannabis users) |
| Interventions | Delta-9-tetrahydrocannabinol (THC) Placebo |
| Dose | >2.1 mg/70 kg (higher doses associated with more adverse events) |
| Duration | Up to 12 months follow-up |
| Topics | Cannabis |
| Key findings | Intravenous THC infusions were associated with relatively low risk: one serious and 70 minor adverse events in 9.7% of subjects and 7.4% of infusions. Faster infusion rates and higher doses increased adverse event likelihood. Long-term follow-up indicated most subjects reported no change or reduced desire to use cannabis. |
Abstract
Delta-9-tetrahydrocannabinol (THC) is one of the few cannabinoid receptor ligands that can be used to probe the cannabinoid system in humans. Despite increasing interest in the cannabinoid receptor system, use of intravenous THC as a research tool has been limited by concerns about its abuse liability and psychoactive effects. This study aims to evaluate the safety of all intravenous THC studies conducted at this center for the past 13 years. Included were 11 studies with 266 subjects (14 schizophrenia patients and 252 healthy subjects, of whom 76 were frequent cannabis users), 351 active THC infusions, and 226 placebo infusions. Subjects were monitored for subjective and physical adverse events and followed up to 12 months beyond study participation. There was one serious and 70 minor adverse events in 9.7% of subjects and 7.4% of infusions, with 8.5% occurring after the end of the test day. Nausea and dizziness were the most frequent side effects. Adverse events were more likely to be associated with faster infusion rates (2-5 min) and higher doses (>2.1 mg/70 kg). Of 149 subjects on whom long-term follow-up data were gathered, 94% reported either no change or a reduction in their desire to use cannabis in the post-study period, 18% stated that their cannabis use decreased, and 3% stated that it increased in the post-study period. With careful subject selection and screening, risk to subjects is relatively low. Safeguards are generally sufficient and effective, reducing both the duration and severity of adverse events.
Comparable studies
Other observational and cohort studies on cannabis, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| High-potency cannabis and the risk of psychosis People with first episode of psychosis and healthy controls from the local population | 2009 | Case-control study | n = 454 |
| Ayahuasca-Assisted Therapy for Addiction: Results from a Preliminary Observational Study in Canada Rural aboriginal population | 2013 | Observational study | |
| Impaired cognitive performance in drug free users of recreational ecstasy (MDMA) Otherwise healthy young people | 2000 | Observational | |
| Continued cannabis use and risk of incidence and persistence of psychotic symptoms: 10 year follow-up cohort study Individuals from the general population in Germany aged 14-24 at baseline | 2011 | Observational cohort | n = 1,923 |
| Cannabis-induced psychosis and subsequent schizophrenia-spectrum disorders: follow-up study of 535 incident cases Patients treated for cannabis-induced psychotic symptoms in Denmark between 1994 and... | 2005 | Observational cohort | n = 535 |
Citations in the library
Cited by 10
- Human Laboratory Studies on Cannabinoids and Psychosis. Biological Psychiatry April 1, 2016
- Sex differences in the acute effects of oral THC: a randomized, placebo-controlled, crossover human laboratory study. Psychopharmacology October 1, 2024
- Sex differences in the acute effects of intravenous (IV) delta-9 tetrahydrocannabinol (THC). Psychopharmacology May 2022
- Characterizing psychosis-relevant phenomena and cognitive function in a unique population with isolated, chronic and very heavy cannabis exposure Psychological Medicine October 16, 2019
- The dose-dependent psychomotor effects of intravenous delta-9-tetrahydrocannabinol (Δ9-THC) in humans. Journal of Psychopharmacology December 2018
and 5 more in the library
Cites 12
- Comparative and Interactive Human Psychopharmacologic Effects of Ketamine and Amphetamine Archives of General Psychiatry September 1, 2005
- Synthetic delta-9-tetrahydrocannabinol elicits schizophrenia-like negative symptoms which are distinct from sedation. Human psychopharmacology January 2011
- Disruption of frontal θ coherence by Δ9-tetrahydrocannabinol is associated with positive psychotic symptoms. Neuropsychopharmacology December 8, 2010
- Opposite effects of delta-9-tetrahydrocannabinol and cannabidiol on human brain function and psychopathology. Neuropsychopharmacology November 18, 2009
- The acute effects of synthetic intravenous Delta9-tetrahydrocannabinol on psychosis, mood and cognitive functioning. Psychological Medicine October 2009
and 7 more in the library